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Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma
Not Recruiting
Trial ID: NCT00066365
Purpose
RATIONALE: Inhaling aerosolized sargramostim before and after surgery may interfere with the
growth of tumor cells and shrink the tumor so that it can be removed during surgery.
Sargramostim may then kill any tumor cells remaining after surgery. This may be an effective
treatment for osteosarcoma that has spread to the lung.
PURPOSE: This phase II trial is studying how well inhaled sargramostim works in treating
patients who are undergoing surgery for the first recurrence of osteosarcoma that has spread
to the lung.
Official Title
A Phase II Study of Aerosolized GM-CSF (NSC# 613795, IND# 11042) in Patients With First Pulmonary Recurrence of Osteosarcoma
Stanford Investigator(s)
Eligibility
DISEASE CHARACTERISTICS:
- Histologically confirmed osteosarcoma at primary diagnosis
- Lesions detected in at least 1 lung that are consistent with metastatic disease
and approachable with thoracotomy
- No prior recurrence of osteosarcoma
- No other sites of metastases
- Resectable pulmonary nodule(s), defined as nodule(s) that are removable without
performing a pneumonectomy (e.g., nodules immediately adjacent to the main stem
bronchus or main pulmonary vessels)
- Prior thoracotomy allowed in patients with imaging consistent with metastatic
involvement in both lungs provided the lung on which the thoracotomy was performed is
disease-free
- No pleural effusion or pleural based nodules
PATIENT CHARACTERISTICS:
Age
- 39 and under
Performance status
- Karnofsky 50-100% (patients over 16 years of age)
- Lansky 50-100% (patients 16 years of age and under)
Life expectancy
- At least 8 weeks
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Pulmonary
- No evidence of dyspnea at rest
- No exercise intolerance
- Pulse oximetry at least 94%
- Baseline Forced expiratory volume in 1 second (FEV_1) at least 80% of predicted
- No history of asthma
- No history of reactive airway disease
- No history of bronchospasm
Other
- Willing and able to perform inhalation therapy
- No medical contraindication to surgical excision
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No other concurrent immunotherapy
- No other concurrent immunomodulating agents
Chemotherapy
- No concurrent anticancer chemotherapy
Endocrine therapy
- No concurrent steroids by any route
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
- No concurrent thoracoscopy or video-assisted thoracic surgery
Other
- No more than 1 prior treatment regimen for osteosarcoma
- No concurrent participation in another COG therapeutic study
Intervention(s):
biological: sargramostim
procedure: conventional surgery
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Peds Hem/Onc CRAs
650-723-5535